Clinical trial · Observational
Biomarkers for Breast Cancer Risk in African American Women
Epigenetics and Breast Cancer Risk in African American Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: \- At present, women do not have very accurate tests to inform of them of their personal risk of developing breast cancer. More information on the changes associated with both benign and cancerous breast lesions will help develop better risk information. Researchers have been looking at cells found in breast milk to study genetic changes related to breast cancer. However, most of these cell samples have been collected from white women. A new study wants to collect breast milk samples from African American women for further research. Comparing the results of genetic tests will help improve understanding of breast cancer risk in all women. Objectives: \- To study genetic changes related to breast lesions, including breast cancer, in African American women. Eligibility: \- African American women at least 18 years of age who are nursing a baby and who either have had or are being considered for a breast biopsy. Design: * Participants will be screened with personal health questions. * Participants will receive a box with sterile bottles for milk collection. They will collect two breast milk samples, one from each breast. They will also fill out a questionnaire about their medical history. * The box with the samples and the questionnaire will be returned to the clinical center for study. * After the box is returned, participants will be asked to provide a copy of the biopsy report for any breast biopsies they have had. * There will be a followup phone call every year. Participants will provide health history information. This information will include whether they have been diagnosed with breast cancer in the previous year.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Volunteers
- description
- Volunteer milk donors
Primary outcomes (1)
- measure
- breast cancer biomarkers
- timeFrame
- various time points throughout study conduct
- description
- breast cancer risk
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 10 Years
- Maximum age
- 50 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Any woman who identifies as African American, Black, or African * Currently nursing a baby * Able and willing to sign written informed consent * Willing to be contacted by study personnel for follow-up to determine whether a biopsy took place * Willing to have her milk sample archived for future analyses EXCLUSION CRITERIA: * The woman does not consider herself to be of African American, Black, or African. These women may participate in the other ongoing Breast Milk Study at University of Massachusetts. * Unable to sign written Informed Consent or Assent Form. * Unwilling to be contacted by study personnel.
References
Publications (1)
- BACKGROUNDMurphy J, Sherman ME, Browne EP, Caballero AI, Punska EC, Pfeiffer RM, Yang HP, Lee M, Yang H, Gierach GL, Arcaro KF. Potential of breastmilk analysis to inform early events in breast carcinogenesis: rationale and considerations. Breast Cancer Res Treat. 2016 May;157(1):13-22. doi: 10.1007/s10549-016-3796-x. Epub 2016 Apr 23. PMID 27107568